A new potential treatment for multiple sclerosis that many thought might be helpful to patients turned out not to be so. Researchers at SUNY Buffalo found no difference in clinical symptoms, brain lesions, or quality of life outcomes between MS patients who underwent balloon angioplasty to correct chronic cerebrospinal venous insufficiency (CCSVI) and those who did not.
The novel treatment was based on an unproven theory that MS may, in part, be caused by reduced blood flow from the brain because of narrowed or blocked veins. The theory was that, similar to heart procedures, balloons could be used to open those veins. The intervention is sometimes called “Liberation Therapy.”
Researchers studied 30 MS patients, most from Western New York. Ten were involved in the first phase, a safety trial; 20 were randomized to receive treatment or placebo during the second.
“What we found was rather surprising and unexpected,” says principal investigator Adnan Siddiqui, MD, an associate professor of neurosurgery at UB “It was quite the opposite of what we originally expected to find. The study showed that endovascular treatment of the veins had no effect in MS patients.”
UB’s is believed to be the first prospective, randomized, double-blind, controlled study of balloon angioplasty for this condition. Researchers at the UB School of Medicine and Biomedical Sciences were “uniquely situated” to study this important question, Siddiqui says. “Some of the world’s leaders in stroke intervention, in the Department of Neurosurgery, are located right next door to some of the world leaders in multiple sclerosis, in the UB Department of Neurology, and in imaging at the Buffalo Neuroimaging Analysis Center,” he says.
Since 2009, approximately 30,000 MS patients worldwide have undergone interventional endovascular therapy; the vast majority of them were not in clinical trials.
The UB researchers stress that their trial was small and that larger, similarly rigorous studies should be undertaken.
“This is not the last word on this endovascular treatment for MS,” Siddiqui says. “However, these findings lead us to caution strongly against the general acceptance of this invasive procedure for MS patients.”
The novel treatment was based on an unproven theory that MS may, in part, be caused by reduced blood flow from the brain because of narrowed or blocked veins. The theory was that, similar to heart procedures, balloons could be used to open those veins. The intervention is sometimes called “Liberation Therapy.”
Researchers studied 30 MS patients, most from Western New York. Ten were involved in the first phase, a safety trial; 20 were randomized to receive treatment or placebo during the second.
“What we found was rather surprising and unexpected,” says principal investigator Adnan Siddiqui, MD, an associate professor of neurosurgery at UB “It was quite the opposite of what we originally expected to find. The study showed that endovascular treatment of the veins had no effect in MS patients.”
UB’s is believed to be the first prospective, randomized, double-blind, controlled study of balloon angioplasty for this condition. Researchers at the UB School of Medicine and Biomedical Sciences were “uniquely situated” to study this important question, Siddiqui says. “Some of the world’s leaders in stroke intervention, in the Department of Neurosurgery, are located right next door to some of the world leaders in multiple sclerosis, in the UB Department of Neurology, and in imaging at the Buffalo Neuroimaging Analysis Center,” he says.
Since 2009, approximately 30,000 MS patients worldwide have undergone interventional endovascular therapy; the vast majority of them were not in clinical trials.
The UB researchers stress that their trial was small and that larger, similarly rigorous studies should be undertaken.
“This is not the last word on this endovascular treatment for MS,” Siddiqui says. “However, these findings lead us to caution strongly against the general acceptance of this invasive procedure for MS patients.”
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